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中成药创新迈向2.0时代:企业转型、需求驱动、加速转化
Mei Ri Jing Ji Xin Wen· 2025-04-29 02:20
Core Insights - The traditional Chinese medicine (TCM) industry is shifting from policy-driven growth to innovation-driven growth, with a focus on high-quality development and meeting unmet clinical needs [7][12] - The approval of new TCM drugs is accelerating, with significant increases in clinical trial applications and new drug approvals, indicating a robust pipeline for innovation [2][6] Industry Trends - The market size of the TCM industry is projected to reach 599.3 billion yuan by 2030, reflecting continuous growth [2] - In 2024, the National Medical Products Administration (NMPA) received 100 clinical trial applications and 40 new drug applications for TCM, showcasing a trend of increasing innovation [2][6] Competitive Landscape - The respiratory system TCM market is experiencing intensified competition, with some leading products facing challenges while others focusing on unique and innovative offerings show resilience [5][12] - The top 20 respiratory TCM products saw 9 out of 20 being unique products, indicating a trend towards differentiation in the market [5] R&D and Innovation - The successful development of "999 Yiqi Qingfei Granules" exemplifies the integration of traditional Chinese medicine principles with modern clinical research methodologies, addressing a gap in the market for respiratory recovery medications [9][10] - The R&D investment by companies like China Resources Sanjiu is significant, with a reported investment of 953 million yuan in the previous year, reflecting a compound annual growth rate of 13.2% from 2020 to 2024 [12] Regulatory Environment - Recent policy changes and the establishment of a specialized regulatory framework for TCM are facilitating the development and approval of new TCM drugs, enhancing the industry's growth prospects [8][12] - The new medical insurance directory has accelerated the inclusion of innovative TCM drugs, reducing the time from market entry to insurance coverage to under two years [6][12]